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Tighter REMS For Zohydro ER Still Insufficient For FDA Advisory Panel

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.

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